Time for a temperature reading. You may recall that only last month an FDA advisory committee decided OTC cough and cold meds shouldn’t be used by children younger than 6 years old since there was no evidence the meds are effective, but could prove harmful.

And so despite the onset of flu season, sales have dropped more than 16 percent in the four weeks ended Nov. 3, compared with both the previous four-week period and the same period a year earlier, The Washington Post reports. The same trend was noted earlier this month following the Oct. 19 panel meeting.

“Historically, sales of these products are on an upswing at this time of year,” Jennifer Frighetto of ACNielsen, the market research firm that tracks product sales, tells the Post. “Based on the historical sales, one would have expected to see an increase, not a decrease.” Americans spent $21.1 million on the meds during the four weeks, the most recent period for which data is available, down from a little more than $25.3 million during the previous four weeks, the firm reported.

“This is good news,” clucks Baltimore Health Commissioner Joshua Sharfstein, who is leading the drive to get the FDA to restrict the products. “This is a plus for child health. Fewer parents are giving unproven and potentially unsafe drugs to their children.”

Drugmakers, however, maintain the remedies are safe and effective, and said it is too soon to attribute the drop to the recent criticisms of them. “It’s premature to make the connection that a drop in sales is directly the result,” Elizabeth Funderburk of the Consumer Healthcare Products Association, tells the Post. “It’s not surprising at this point to see that drop, given that it’s been a mild cold season so far this year.”

Several pediatricians disagreed, saying they had seen many parents in recent weeks who said they had stopped giving the meds to their children since hearing about the warnings. “It really frightened a lot of parents,” Joanna Sexter of Spring Valley Pediatrics tells the paper. “Sometimes, these stories come out, and parents challenge it and pooh-pooh it. This time, that didn’t happen. I’ve had a lot of parents say they just threw it all away.”

That was the case for Laura Moorer, a law librarian from Rockville, Md. Even though she thinks the remedies have helped her 2 1/2 -year-old daughter, Katie, in the past, Moorer and her husband decided not to use any when she was hit by a bad cold several weeks ago.

“We kept her home from preschool and watched her spend several days in misery, and I felt bad we could not do something to alleviate the coughing and discomfort she was feeling,” she says. “But I was also concerned enough not to let her use the medication. So we went back to home remedies: elevated pillow, humidifier, steamy shower, not much milk, clear fluids and extra TLC.” Some of her friends have also sworn off the products, but some parents have not.

“We’ve used them for years. We think they’re very safe,” says Randy Tidd of McLean, Va., adding that he and his wife still give the remedies to their 4-year-old son, Oscar, and 2-year-old daughter, Louisa, who was hit hard recently by a nasty cold. “She wasn’t sleeping or eating. Some days she would cough so much, she would throw up,” he says. “We gave her a dose recommended by the pediatrician, and she went from crying and fussing and not sleeping and not eating to within 15 to 20 minutes her symptoms disappearing. She took a huge nap and woke up much better. For both of our kids, the cause and effect is really crystal clear.”

The controversy began when Sharfstein and others petitioned the FDA last spring to restrict use of the products, citing the lack of evidence that they work and reports of children suffering hallucinations, seizures, trouble breathing, heart problems and occasional deaths. The petition prompted the agency to convene a special panel of experts for a two-day hearing.

A week before the FDA panel met, major drugmakers voluntarily pulled all products for children younger than 2 but said the problems were overwhelmingly caused by parents inadvertently giving overdoses. But after an exhaustive review, the panel concluded there was little evidence the remedies worked for children younger than 12 and recommended they not be used at all in those younger than 6.

The industry, however, has vowed to keep the products on the market, saying they offer relief for older children as long as they are used according to directions. The companies are spending an estimated $50 million a year to sustain at least $300 million in annual sales, according AC Nielsen’s figures, which do not include Wal-Mart.

The case illustrates the limits of the FDA’s authority to regulate over-the-counter drugs. Although the agency is reviewing the advisory panel’s recommendations, officials have said their ability to act quickly is restricted by the law.

In response, three DC pols - Ted Kennedy, Henry Waxman and Tom Allen - have introduced legislation that would give the agency power to pull such products from the market more easily. “When American consumers buy OTC drugs, they expect them to be safe and to actually work,” Waxman said in a statement. “If we don’t get FDA the authority it needs to act quickly, Americans will continue to expose themselves to drugs that may not work, but may pose risks.” Here is the bill.

Sharfstein said he hopes the FDA will issue a statement advising against using the products as it initiates regulatory action. “The companies are still aggressively promoting these products for young children,” he says. “Unless the FDA makes a clear statement, the marketing is eventually going to drive consumption back up. I think the FDA should make a clear statement about what the science shows as they start whatever legal process is necessary to stop the marketing of these products for kids under age 6.”

Officials said they are reviewing the situation. “FDA is in the process of developing the policy on this issue,” says Charles Ganley, director of FDA’s office of OTC drugs. Funderburk says drugmakers have launched an educational campaign aimed at helping parents use the meds more safely.

In the meantime, parents are making their own decisions. Tidd says many of his friends were still using the products. “This is how we’ve been treating colds ever since they were born,” he says, adding that he and his wife are hoarding the bottles they have, anticipating that the remedies will eventually disappear from drugstore shelves. “We have a whole drawer full of the contraband, and we’re holding onto it.”

Source: The Washington Post